Join Date: Aug 2003
Location: Restless Genital Syndrome
Suff erer Club
OT: Please Critique my resume
Critique, prease, if j00 are bored or want somethin' to do
Dokt4r B. DRum
123 Happy Street
Byron Center, MI, 49315
Phone: (800) EAT-CRPT
Seeking Quality Engineering position where my quality assurance experience in FDA compliant pharmaceutical and biologics manufacturing facilities can be utilized to improve product quality, operations, and company profits.
- Knowledge of quality systems, sterile manufacturing facilities, cGMPs, Part 211 and 11 FDA regulations
- Participated and assisted in two FDA Inspections/Quality Audits
- Experience in manufacturing, process validation, new project management, critical utilities (WFI, Class 100, laminar air) and cleaning validation in pharmaceutical and biologics (vaccine) manufacturing environments
- Sterility assurance including lethality and biological indicator testing
- Excellent teamwork, leadership, manufacturing, communication (written, oral and presentation) and computer skills (MS Office, MS Project, Kaye Validator and CAD)
2/2002 – Present.....A vaccine makin’ place......Lansing, MI
Validation and Quality Assurance Engineer......2/2002 – Present
- Execute qualification studies on: autoclaves, sterilization systems, bulk production and storage vessels, controlled temperature units (including product shipping and transportation systems, refrigeration units, cryo freezers and CO2 incubators), laminar air flow environments, classified air zones, laboratory equipment.
- Write documentation for validation, installation/operation/performance/process qualifications (IQ, OQ, PQ, PV), standard operating procedures (SOP), failure investigation, corrective action, risk analysis, scope, specification and training.
- Performed many deviation identifications, failure investigations (FMEA), root cause analyses and corrective action applications on equipment and processes.
- Aseptic handling, processing, production and sterility assurance (lethality and biological indicator) experience
- Process and equipment design, development, commissioning, troubleshooting and continuous improvement.
5/1998 - 10/2001......A big pharmaceutical company......Kalamazoo, Mi
Process and Validation Engineer......3/2001 - 10/2001
- Projects included pharmaceutical clean rooms, full-scale and pilot-plant scale production equipment.
- Developed full-scale pharmaceutical productions facilities including utility testing, process development and productions equipment support with team of engineers and technicians.
- Wrote and edited Process and Instrumentation Diagrams (P&IDs), Process Flow Diagrams (PFDs) and other process diagrams for full, pilot plant and lab scale projects
- Planned project stages and details to a time schedule and coordinated team to maintain established schedule
Process and Project Engineer.......4/1998 - 2/2001
- Led and completed process and manufacturing improvement initiatives for profit, cost and time benefits.
- Developed plant-wide energy savings project utilizing several waste management techniques. Improved efficiency and cost savings by monitoring, tuning and scheduling equipment and plant processes.
- Arranged, prepared and led meetings regarding process and production improvement
- Established and led training program for production-scale operations with instruction manual
- Created and implemented preventative maintenance and validation program for site-wide transfer methods.
QA Training Courses – pharmaceutical water, risk-based validation, equipment, cleaning, computer/automation
BSE (Chemical Engineering Major, Chemistry Minor) – 5/2001, Calvin College
References furnished upon request
CN: It's my bloody resume